Wound treatment system and method of use

ABSTRACT

A wound treatment system includes a vessel that is sized to receive a human limb. The vessel includes a chamber with an opening leading into the chamber A removable liner lines the chamber of the vessel and forms a treatment zone. A humidifier in fluid communication with the treatment zone humidifies a solution of water and antibacterial agent. An oxygen source is in fluid communication with the treatment zone. A speaker is coupled to the vessel and emits low frequency sound waves to the chamber. a first array of light emitting diodes that emits ultraviolet light is coupled to the vessel near the opening of the treatment chamber. A second array of light emitting diodes that emits pulsed light into the chamber is coupled to the chamber. The system also includes a control panel.

TECHNICAL FIELD

The present disclosure relates in general to wound treatment systems.More particularly, the present disclosure relates to a wound treatmentapparatus and system for treatment of surface wounds.

BACKGROUND

Medical professionals and healthcare providers such as nurses anddoctors routinely treat patients having surface wounds of varying size,shape and severity caused by skin ulcerations due to diabetes, venousstasis, post surgical infections, gangrenous lesions, decubitus ulcers,amputations, skin grafts, burns, and frostbite. Variations in wound typeand other patient indications dictate variations in desired medicationsfor treatment, such as antibiotics, growth factors, enzymes, hormones,protocols, such as delivery rates for medication and temperaturecontrol.

One particular area of concern involves foot or limb wounds in diabeticpatients. It is known that foot wounds in diabetic patients represent asignificant public health problem throughout the world. Diabetes is alarge and growing problem in the United States and worldwide, costing anestimated $45 billion dollars to the U.S. health care system. Patientsafflicted with diabetes often have elevated glucose and lipid levels dueto inconsistent use of insulin, which can result in a damagedcirculatory system and high cholesterol levels. Often, these conditionsare accompanied by deteriorating sensation in the nerves of the foot. Asa result, diabetics experience a high number of non-healing foot ulcers.

It is estimated that each year up to three million leg ulcers occur inpatients in the U.S., including venous stasis ulcers, diabetic ulcers,ischemic leg ulcers, and pressure ulcers. The national cost of chronicwounds is estimated at $6 billion. Diabetic ulcers often progress toinfections, osteomyelitis and gangrene, subsequently resulting in toeamputations, leg amputations, and death. In 1995, approximately 70,000such amputations were performed at a cost of $23,000 per toe and $40,000per limb. Many of these patients progress to multiple toe amputationsand contralateral limb amputations. In addition, the patients are alsoat a greatly increased risk of heart disease and kidney failure fromarteriosclerosis which attacks the entire circulatory system.

The conventional methods of treatment for non-healing diabetic ulcersinclude wound dressings of various types, antibiotics, wound healinggrowth factors, skin grafting including tissue engineered grafts, use ofwheelchairs and crutches to remove mechanical pressure, and finallyamputation. In the case of ischemic ulcers, surgical revascularizationprocedures via autografts and allografts and surgical laserrevascularization have been applied with short term success, but withdisappointing long term success due to reclogging of the grafts. In thetreatment of patients with venous stasis ulcers and severe venousdisease, antibiotics and thrombolytic anticoagulant and anti-aggregationdrugs are often indicated. The failure to heal and the frequentrecurrence of these ulcers points to the lack of success of theseconventional methods. Accordingly, the medical community has a criticalneed for a low cost, portable, non-invasive method of treating diabetic,venous, ischemic and pressure ulcers to reduce mortality and morbidityand reduce the excessive costs to the health care system.

Most problematic of all is that treatment of diabetic foot ulcers hasbeen focused on amputation and not on limb salvage, as many of thewounds have not been properly treated. Improper treatment can beattributed to lack of an easy and inexpensive treatment system andmethod and severe inconvenience to the patient in using current methods.There is a need to prevent amputation by healing such wounds,particularly at an early stage.

Furthermore, amputation for conditions such as foot ulcers and frostbitebecomes less avoidable the longer the condition is either left untreatedor is unsuccessfully treated. Therefore, it is crucial to apply aneffective treatment regimen as soon as possible. Unfortunately, footwounds in patients with, for example, diabetes develop because of aprocess called neuropathy. Diabetes causes loss of sensation such thatskin injury and complete breakdown (ulcer) can develop with no orminimal pain. These wounds tend not to heal because of ongoingmechanical trauma not felt at all by the patient as painful. Therefore,by the time the patient discovers the wound, the wound has oftenprogressed so that the patient's treatment options have become severelylimited.

In many cases, such wounds can only be healed by protecting them frommechanical trauma. Small plantar ulcers in diabetic patients areausually seen by primary care practitioners and endocrinologists. Thepresent method for healing plantar ulcers is a total contact cast forthe foot, which provides complete mechanical protection. This method isnot ideally suited for either of these practice settings, because itrequires skilled and specialized care in application, along withfrequent follow up. Most patients perceive the cast to be aninconvenience at the early stages of such a wound, while perceiving thatsuch a wound is not a serious matter. The alternative to the cast is toask the patient to be non-weight bearing through the use of awheelchair, crutches, or a walker, which provide complete mechanicalprotection only with complete patient compliance. This alternativerarely proves to be effective in healing wounds within a reasonable timeperiod.

What is needed is a treatment that primary care physicians and theirstaff can employ to treat ulcers and other wounds that does not requireextended physician time and that is effective even at later stages ofwound progression. Also, what is needed is a treatment that allowspatients to be able to continue their active lives without the need towear casts, or be confined to wheelchairs and crutches.

SUMMARY

In one embodiment, a wound treatment apparatus includes a treatmentvessel having a treatment chamber and one or more openings to thetreatment chamber that are each sized to receive a human limb. Aremovable and substantially gas impermeable liner lines the chamber ofthe vessel and forms a treatment zone around the patient's limb. A cuffis removably coupled to the opening of the vessel and is sized tosealingly engage a human limb when the limb is inserted through theopening. A mixture tank holds a humidifying agent and is in fluidcommunication with the chamber of the vessel. A first array of lightemitting diodes is coupled to the chamber and emits ultraviolet lightinto the chamber. A speaker is attached to the vessel and delivers lowfrequency sound waves to the chamber. A second array of light emittingdiodes is coupled to the chamber and emits pulsed light into thechamber.

A wound treatment system includes a vessel that is sized to receive ahuman limb. The vessel includes a chamber with an opening leading intothe chamber. A removable liner lines the chamber of the vessel and formsa treatment zone. A humidifier in fluid communication with the treatmentzone humidifies a solution of water and antibacterial agent. An oxygensource is in fluid communication with the treatment zone. A speaker iscoupled to the vessel and emits low frequency sound waves to thechamber. A first array of light emitting diodes that emits ultravioletlight is coupled to the vessel near the opening of the treatment chamberand wherein the first array of light emitting diodes emits light withina frequency range sufficient to reduce or destroy bacteria. A secondarray of light emitting diodes that emits pulsed light into the chamberis coupled to the chamber. The system also includes a control panel.

A wound treatment method for treating a wounded limb is also described.The method includes cleaning the wound. The method also includesdisinfecting the limb by passing the limb through a ring of ultravioletlight emitting diodes that emit ultraviolet light on the limb as thelimb passes through the ring. The limb is placed into a vessel having achamber that is lined with a substantially gas impermeable liner bypassing the limb through a cuff that sealingly surrounds a portion ofthe limb, thus forming a substantially gas impermeable treatment zonearound a portion of the limb distal the cuff. The limb is heated byintroducing warm water into the chamber, which causes the inner liner tocollapse around the patient's limb. The warm water is emptied out of thechamber, and a temperature controlled mist of topical oxygen, water andan antibacterial solution is introduced into the treatment zone. Thelimb is massaged by activating a speaker coupled to the vessel thattransmits low frequency sound waves to the treatment zone. The limb isheated and kept warm by activating an array of light emitting diodescoupled to the vessel that emits pulsed light onto the limb.

DESCRIPTION OF DRAWINGS

These and other features and advantages will be apparent from thefollowing more particular description thereof, presented in conjunctionwith the following drawings, wherein:

FIG. 1 is a three-dimensional view of a wound treatment system.

FIG. 2 is a is an illustration of a control panel of a wound treatmentsystem.

FIG. 3A is another three-dimensional view of the wound treatment systemdepicted in FIG. 1.

FIG. 3B is a three dimensional view of the wound treatment systemdepicted in FIG. 1 with patient being treated.

FIG. 4A is a three dimensional view of a lid assembly of a woundtreatment system.

FIG. 4B is a three dimensional view of a treatment vessel of a woundtreatment system.

FIG. 5 is a side exploded view of a treatment vessel of a woundtreatment system.

FIG. 6A is a front transparency view of the treatment vessel depicted inFIG. 5.

FIG. 6B is a top view of the wound treatment tank depicted in FIG. 5.

FIG. 7A is a front transparency view of a wound treatment chamber.

FIG. 7B is a bottom view of the wound treatment chamber depicted in FIG.7B.

FIG. 8A is a rear view of a wound treatment system with a rear panelremoved.

FIG. 8B is another rear view of the wound treatment system depicted inFIG. 8B further depicting a humidifier.

FIG. 9A is a front transparency view of a water reservoir used in awound treatment system.

FIG. 9B is a side transparency view of the water reservoir depicted inFIG. 9A.

DETAILED DESCRIPTION

The apparatus, systems, and methods described herein provide oxygen toopen, chronic wounds as an adjunct therapy in wound management andtreatment. In addition, per determination by the healthcare providersthat use the described apparatus, systems, and methods, they can alsoprovide mild heat, gentle massage, infrared and ultraviolet lighttherapy, moisture therapy, and application of antibacterial agents.These features are intended to promote the rate of healing andsuppression of bacterial growth. The oxygen therapy described herein isHyperoxia, which is distinguished from hyperbaric oxygen which isexposure to oxygen at greater than atmospheric pressure. An ATA ofgreater than 1.2 is hyperbaric oxygenation; below that value it isconsidered Hyperoxia or topical oxygen.

As described below, the Hyperoxia, gently moisturizing vapor, andantimicrobial features collectively provided advantages that HyperbaricOxygen chambers can not provide. Oxygen promotes angiogenesis. Thedisclosed device soaks a wound tissue in Oxygen instead of trying to“pump it in” The disclosed devices and methods eliminates or reduces therisk of O2 toxicity, a common concern with Topical Hyperbaric Oxygen(THBO) therapy.

Turning to FIG. 1, a wound treatment system 10 is shown, which generallyincludes a topical oxygen chamber for limbs and is intended to surrounda patient's limb and apply humidified water, antibacterial agent, andoxygen topically at a pressure slightly greater than atmosphericpressure. The wound treatment system 10 includes a rectangular, rigidplastic carriage 15 having a treatment vessel 800 forming a chamber 810(shown in FIG. 5) that is sized to accommodate a patient's limb,particularly a patient's foot and a portion of the leg up to the knee.In another embodiment, the system 10 has two or more chambers so thatthe system 10 can accommodate multiple limbs at once. In this regard,the system 10 can include multiple components for a particular limb,such as multiple leg rests, humidifiers, liners, etc. The system 10 canalso be equipped with mechanical attachment devices, such as hoses, thatpermit components of the system to remotely interface with the system10.

A padded leg rest 18 supports the patient's leg during treatmentsessions. The system also includes a control panel 30, a cart 40 housinga first reservoir 600 for water, an adiabatic humidifier 400 that holdsa solution of water and antibacterial agent, a water pump 500 (all shownin FIGS. 8A and 8B), and a control box (beneath the control panel) thathouses the circuit boards that control the system 10. A mist controlvalve unit 50 is attached to a back panel of the cart 40. A hose 70connects the mist control valve unit 50 to the vessel 20, and one ormore hoses 71 connect the humidifier 400 to the mist control valve unit50.

Covering the vessel 800 is a lid assembly 60 (shown in FIGS. 1 and 4A)that includes a first lower lid 61 that is hinged to the vessel 800 atthe proximal end 64 of the vessel 800 opposite the end abutting the backpanel of the cart 40. The lower lid 61 includes a circular opening 161that provides access to a chamber 810 formed inside the vessel.

The lid assembly 60, as shown in FIGS. 1 and 4A, also includes a secondupper lid that is formed by two opposing covers 62 and 63. Cover 62covers the distal side 64 of the vessel 800 and cover 63 covers theproximal side 65 of the vessel 800. The covers 62 and 63 are completelyremovable from the top of the vessel 800. The distal side of cover 63forms a half circular indentation that is matched by a half circularindentation in the proximal side of cover 62 so that when the distalside of cover 63 and the proximal side of cover 62 join, a round opening169 is formed when the covers 62 and 63 are secured over lid 61. Eachcover 62 and 63 has a raised half circular wall 67 and 68 projectingvertically from its top surface around its corresponding half circularindentation. When the covers are joined as shown in FIG. 1, the walls 67and 68 join to form a cylinder 69. The round opening 169 formed when thehalf circular indentations are joined is concentric with the circularopening 161 of the lower lid 61 so that a patient's limb can projectdown through the cylinder 69, through opening 169 formed by the covers62 and 63, through opening 161 of the lower lid 61, and into the chamber830 of the vessel 20.

An oxygen inlet port 77 on the cover 62 (or alternatively cover 63)receives a hose 78 connected to an oxygen source, such as an oxygen tankor a central oxygen source in a hospital. The inlet port 77 can includea fitting (not shown) to sealingly secure the hose 78 to the cover 62.The cover 62 includes a vapor inlet port 72 that receives the hose 70.The vapor inlet port 72 can include a fitting 73 to sealingly secure thehose 70 to the vapor inlet port 72. Either of the covers 62 or 63 canalso include a temperature sensor 92, a humidity sensor 94, and apressure sensor 96, each of which are in fluid communication with atreatment zone formed by a treatment bag 100 sealed to the lid 61 of thevessel (FIG. 4B). The cart 40 includes wheels 41 at each corner tomobilize the system 10.

As shown in FIG. 2, the control panel 30 includes a display with variousknobs and switches that controls the operation of the wound treatmentsystem 10. The panel includes controls 130 that control the humidifier,controls 140 that control an array of ultraviolet light emitting diodes(LEDs) 310 (see FIGS. 4A and 4B) controls 150 that control an array orboard of infrared light 880 (see FIGS. 4B, 6A, and 7A) and an audiotransducer or speaker 870 (see FIGS. 5, 6A, 7A, and 7B), controls 160that control a water pump 500 (see FIG. 8A), and controls 170 thatcontrol the master power for the system 10.

The humidifier functions of the system are controlled by controls 130,which include at least some of the following: an on/off switch 131 thatturns on the humidifier function; a button 132 that can be used tomanually activate or open the mist control valve unit 50 and thatilluminates when the mist control valve unit 50 is open and allowing theflow of therapeutic mist into the chamber 830; a button 133 that opensan electronic oxygen flow valve in the tubing 78 connected to the oxygensource and illuminates when the oxygen flow valve is open and allowingoxygen flow into the chamber 810; an auto/manual switch 134 that setsthe humidifier function to either manual operation or auto operation; amist timer knob 135 that is used to set the amount of time for mist flowinto the chamber 810; and an oxygen timer knob 136 that sets the amountof time for oxygen flow into the chamber 810.

The UV functions of the system is controlled by controls 140, whichinclude at least some of the following: an on/off switch 141 that turnson the UV function; a foot in button 142 that illuminates when thepatient inserts his foot through the opening 169—the collar 300 can havea sensor 360 that senses the foot and sends a signal back to the controlbox to activate the UV LEDS; a UV on button 143 that can be depressed tomanually activate the UV LEDS 310 and that illuminates when the UV LEDS310 are activated; an auto/manual switch 144 that sets the UV functionto either manual operation or auto operation; and an UV timer knob 145that sets the amount of time that the UV LEDS will remain on once theyare activated.

The IR/Audio functions of the system is controlled by controls 150,which include at least some of the following: an on/off switch 151 thatturns on the IR/Audio function; an IR button 152 that can be used tomanually activate the IR LEDS and that illuminates when the IR LEDS andspeaker are operating; an Audio button 153 that can be used to manuallyactivate the speaker or audio transducer and that illuminates when thespeaker is operating; an auto/manual switch 154 that sets the IR/Audiofunction to either manual operation or auto operation; and a timer knob155 that sets the amount of time that the IR LEDS and speaker willremain on once they are activated.

The pump control functions of the system is controlled by controls 160,which include at least some of the following: an an/off switch 161 thatturns on the pump control function; a drain button 162 that can be usedto manually operate the timing of drainage of the chamber 810 and thatilluminates when the chamber 810 is draining; a fill button 163 that canbe used to manually operate the timing of filling the chamber 810 withwarm water and that illuminates when the chamber is filling with water;and an auto/manual switch 164 that sets the pump control function toeither manual operation or auto operation.

The master control buttons 170 include at least some of the following: amaster control switch 171 that turns the system on and off; a startbutton 171 that is used to start the operation of the system and thatilluminates when the system is operating; and a stop button 172 that canbe depressed to prematurely stop the operation of the system.

In one embodiment, the control panel 30 also includes a thermostat (notshown) that is electrically coupled to a submergible water heater 680(see FIG. 9A) that is located in the water reservoir tank 600. Thethermostat can be used to control the temperature of the water that ispumped from the water reservoir tank 600 into the chamber 810.

The system 10 can include various mechanisms and/or software forimplementing data transfer and management. In one embodiment, thecontrol panel 30 or some other portion of the system 10 includes one ormore wireless transmitters adapted to transmit data over a wirelessmedium pursuant to any of a variety of wireless protocols. The system 10can also include one or more wireless receivers for receiving data.Various wireless protocols can be used including, for example,Bluetooth, WiFi, CDMA, etc. The data that is transmitted or received canvary widely. For example, the data can comprise usage data, such asquantity of uses of the system, type of usage, materials used, etc. Suchdata can facilitate data management (such as accounting) in regard tousage of the system 10.

The system 10 can also include other data transfer/management systems,such as a barcode reader that interfaces with a barcode on components ordevices with which that the system 10 interacts. For example, the bagsor liners 100 can each include a barcode that interfaces with a barcodereader for recording usage time, dates, quantity, etc.

In operation, the system 10 works by switching the master power switch170 to the on position, which turns the system on and puts the system inready mode. The healthcare provider then decides which of the functionswill be used in the specific regimen for the particular patient.Depending on the patient and the ailment, the regimen may provide foroperation of all of the functions, or just some of the functions. Forexample, a regimen may call for warming the limb with injection of warmwater into the chamber and then treating the wound with the antibioticmist, but may not require infrared treatment and low frequency soundvibrations. Thus, all of the on/off switches would be switched to theone position except for the IR/Audio control switch 151, which wouldremain in the off position. When operating under normal conditions, allof the functions can be turned on by switching all of the on/offswitches to the on position. This sets all of the functions to readymode. The mist timer knob 135 and oxygen timer knob 136 can then be setto operate for the appropriate amount of time. According to oneembodiment, the mist can be set at about fifteen minutes, while theoxygen is set at about five minutes. The UV timer knob 145 is set tooperate for an appropriate amount of time. According to one embodiment,the UV timer is set to operate for less than 5 seconds, less than 4seconds, less than 3 seconds, less than 2 seconds, or less than 1second. The IR/Audio timer can be set to operate for a period of timecoinciding with the warm water bath of the limb, which is when thechamber is filled with warm water, which warms the limb. This period canlast from about one minute to about ten minutes or more. All of theauto/manual switches can be set to auto for a predetermined and defaultregimen. Next the healthcare provider depresses the start button 171,which begins the regimen.

According to one embodiment, when all of the functions are in operationand auto modes, and the start button 171 is depressed, the systemoperates as follows. First the system waits for the sensor 360 to detectthe insertion of a limb of a patient P, as shown in FIG. 3B) into thechamber 810. After the wound in the limb is cleaned, the limb isinserted through the opening 169 of the covers 62 and 63 and the opening161 of the lid 61. The sensor 360 detects the limb as it passes throughthe opening 161 and activates the UV function, which activates the ringof UV LEDs 310 located concentrically around the opening 161. The UVLEDS 310 briefly stimulate the limb (about one to five seconds) as itpasses through the opening of the chamber 810 and then the UV LEDs 310deactivate. The UV on button 143 illuminates while the UV LEDs are on.

Next, a cuff 90 is placed around the limb and the lids 62 and 63 closedaround the cuff 90 so that the half circular walls 67 and 68 form asubstantial seal around the cuff. The cuff will be discussed in moredetail later. The limb is placed in a bag or liner 100 that issubstantially impermeable to gas. The top opening of the bag 100 issealed to the bottom surface of the lid 61 and forms an airtight sealwith the bottom surface of the lid 61. Thus, when the limb is surroundedby the cuff 90, which is surrounded by the half circular walls 67 and68, the portion of the limb distal the cuff is inside the bag in asubstantially sealed treatment zone.

Once the limb is secured as described, the pump 500 is activated andpumps warm water from the water reservoir 600 to the chamber 810 of thevessel 800 through a hose 510 that is connected to an outlet port 660 inthe reservoir 600 on one end and the pump 500 on the other end. Anotherhose 520 carries the water from the pump 500 to a water pipe protrudingfrom the vessel 20 that is connected to an opening in the chamber 810.The water pump 500 shuts off automatically after a predetermined amountof water is drained from the reservoir 600. The warm water entering thechamber 810 causes the bag 100 to collapse around the limb and creates awarm soothing sensation on the limb. The warm water bath remains in thechamber 810 for a predetermined amount of time, generally between aboutone minute and ten minutes or more. The array of IR LEDs 880 in thechamber 810 is activated and transmits a pulsed (or steady) IR lightduring the warm water bath. The IR LEDS further warm the limb increasingcirculation.

Also contemporaneous with the activation with the IR LEDs 880, the audiotransducer or speaker 870 is activated and generates a low frequencysound wave that surrounds the limb. This creates a massaging effect,stimulates the skin and further enhances circulation. The water pump 500is then activated in reverse and the warm water is pumped out of thechamber 810 and back into the reservoir 600. The IR LEDs 880 and theaudio transducer 870 are turned off.

An adiabatically-humidified, temperature-controlled vapor of water and atopical antibacterial, antiseptic or antibiotic agent is released fromthe humidifier 400 by mist control valve unit 50. The vapor travelsthrough the tube 70 and enters the treatment zone through a port 72 inthe lid 62, which is substantially sealed to the tube 70. The vaporhydrates the wound and provides antibacterial effects. This vaportreatment can last between about two minutes and about thirty minutes,depending on the timer 135 set by the healthcare provider. In oneembodiment, vapor treatment lasts about fifteen minutes. Then the mistcontrol valve unit 50 is activated to close the valve between thehumidifier 400 and the tube 70.

At this time, the oxygen release valve is opened and oxygen flows fromthe oxygen source, which can either be an oxygen tank as shown or a wallmounted oxygen unit connected to a central oxygen source, such as in ahospital setting (not shown). The oxygen tank can be built-in within thesystem 10, such as within the housing of the system, so that the systemis self-contained. Alternately, the oxygen tank can be positioned remotefrom the system 10. In another embodiment, the oxygen tank is replacedwith or used in conjunction with an O2 concentrator, which can be builtdirectly into the system 10 or positioned remote from the system 10. Theoxygen flows through the tube 78 into an oxygen inlet port 77 on thesurface of the lid 62. The oxygen displaces the vapor and oxygenates thewound. Oxygenation can last between about one minute and about fifteenminutes. In one embodiment, oxygenation lasts about five minutes. Theprocess between vapor treatment and oxygenation can be repeated severaltimes. In one embodiment, vapor treatment and oxygenation are repeatedthree times for a total of four rounds of treatment lastingapproximately eighty minutes. The patient's oxygen level can bemonitored during treatment using an oximeter connected to the patient'sfinger or other body part. The oximeter can be electrically connected tothe control circuits in the control box of the system 10, and a displaycan warn the user to stop treatment or introduction of oxygen if thepatient's blood oxygen level is too low or too high according to apredetermined level, such as below 80% saturation for an extended periodof time. An extended period of time can be two or more minutes.

FIG. 3A shows the wound treatment system 10 with the control panel 30lid removed and the lid 61 opened. Underneath the lid of the controlpanel reside the various electronics and circuitry of the system 10. A12V power supply 220 can be used to power the system. A sweep functiongenerator 210 is used to generate a low frequency waveform for the audiofunction. The sweep function generator 210 can generate an adjustablefrequency of between about 1 Hz and about 1000 Hz. It can generatevarious types of waveforms, such as sweeping waveforms and rampingwaveforms within that range of frequencies. The sweep function generator210 produces a sin wave signal that is transmitted to the audioamplifier 230, which can be a 12V amplifier. The amplifier 230 amplifiesthe signal to about 50 W and transmits the amplified signal to thespeaker or audio transducer 870 connected to the vessel 800. The sweepfunction generator 220 can be preset to a default frequency andwaveform. In one embodiment, it can be preset to generate a 60 Hzsignal, which can be manually altered to produce a signal at otherfrequencies between the range of about 1 Hz and about 1000 Hz. Anassembly control cable 240 connects the control box (not shown) with theelectronic components of the system. The control box (not shown), whichis housed underneath the control panel lid 30, houses all of the circuitboards required to operate the system 10.

In one embodiment, as shown in FIGS. 3A and 4B, on the bottom surface61B of the lid 61 is a circular collar 300 that forms a perimeter aroundthe opening 161 on the bottom surface 61B of the lid 61. An array of UVLEDs 310 is mounted on the inner surface of the collar forming a ring.The UV LEDs 310 each point toward the center of the opening 161. Therecan be as few as four LEDS and as many as one hundred twenty or moreLEDs in the array of UV LEDs 310. The array of UV LEDs 310 can deliver330 W of UVA at about 320 nm to about 400 nm. Alternatively, or inaddition to, the array of UV LEDs 310 can deliver 330 W of UVB at about290 nm to about 320 nm. Alternatively, or in addition to, the array ofUV LEDs 310 can deliver 330 W of UVC at about 100 nm to about 200 nm. Inone embodiment, there are ninety UV LEDs delivering 330 W of UVA atabout 374 nm to about 392 nm, delivering a total of about 324 mW or 324W. The collar 300 also includes a motion sensor 360 to detect when alimb has been inserted through the collar and the ring of UV LEDs 310.The motion sensor is connected to the control box through a wire 312that is threaded through a hole in the collar and then a hole in thebottom of the carriage 15 and up through the bottom of the cart 40. Thewire 312 is eventually bundled in the cable 240 and carries anelectrical signal to the circuitry in the control box. The array of UVLEDs 310 receives its electrical signals from the control box through awire 311 that is also threaded through the hole in the collar and then ahole in the bottom of the carriage 15 and up through the bottom of thecart 40 and eventually bundled in the cable 240.

The array of LEDs 310 can also function as a sterilization field in thatthe LEDs 310 emit light within a range of frequencies sufficient toreduce or destroy bacteria. Thus, the array of LEDs acts as anantibacterial device. In this regard, the LEDs can emit light in thefrequency range of about 290 nm to about 260 nm. It should beappreciated that the frequency range can be varied to vary the level ofsterilization.

The lid 61 is raised by lifting the distal side of the lid while theproximal side pivots along its hinges. Chains or wires 85 are connectedat one of their ends to the bottom surface 61B of the lid 61 and attheir other ends to the back panel of the cart with hooks or othersecurement means. The lid 61 falls back and is supported by the chains85. The bottom surface 61B of the lid 61 includes a gasket 184 aroundit's square or rectangular perimeter that seals the bottom surface 61Bof the lid 61 to the vessel 800 when the lid 61 is closed.

As shown in FIG. 4A, the lid 61 can have a substantially circular crown350 projecting vertically from its upper surface 340. This crown is inlieu of the collar 300 shown in FIGS. 3A and 4B. The array of UV LEDs310 is coupled to the inside surface of the crown 350, as is the motiondetector 360. The upper lid is formed by covers 62 and 63. Each of thecovers 62 and 63 can form a corresponding half washer shaped raisedportion 62 and 63. Projecting vertically from the center of each raisedportion 62 and 63 is a half circular wall 67 and 68. When the covers 62and 63 are placed over the lid, the washer shaped raised portions 62 and63 join to form a raised washer shaped portion that fits over thecircular crown 350 to form a substantial seal between the outer wall ofthe crown 350 and the inner wall of the washer shaped raised portion.The outer wall of the crown 350 can include a gasket (not shown) toreinforce the seal. The half circular walls 67 and 68 also join to forma cylinder with an opening 169 in the center that is concentric with andopen to the opening 161 of the lid 61.

An oxygen inlet port 77 on the washer shaped raised portion 62 (oralternatively on washer shaped raised portion 63) receives a hose (notshown) connected to an oxygen source, such as an oxygen tank or acentral oxygen source in a hospital. The oxygen inlet port 77 caninclude a fitting (not shown) to sealingly secure the hose to the coverraised portion 62. The raised portion 62 includes a vapor inlet port 72that receives the hose 70 (shown in FIG. 1). The vapor inlet port 72 caninclude a fitting 73 (shown in FIG. 1) to sealingly secure the hose 70to the vapor inlet port 72.

There are only two components of the wound treatment system 10 that makephysical contact with the patient's skin: a liner or bag 100 (as shownin FIGS. 3A and 4B) into which the patient's limb is placed; and a foamcuff 90 (as shown in FIGS. 3B and 4A), which is placed around thepatient's limb.

The liner 100 forms a treatment zone around the wound and makes contactwith the open wound. Therefore, it is preferable that the liner 100 bebiocompatible and sterile. The liner 100 can be discarded or sterilizedafter each use and/or replaced with a new or sterilized liner 100.

The material from which the liner 100 is made can be any strongsubstantially gas impermeable material. Extruded flexible plastic filmmaterial, such as polyethylene (hdpe, ldpe, lldpe, polyprolene, etc,),polyurethane ether, polyethylene terephthalate, polyvinyl chloride, orethylene/polyvinyl copolymer sheet stock, and vapor proof treatedfabric, such as nylon, are suitable. The material can be punctureresistant and transparent. The flexible sheet material can have avariety of shapes. It can be a single layer, such as a bag to surround alimb, or have multiple layers. The bag or liner 100 may also be co ortri axially oriented.

The term “substantially gas impermeable”, as used herein with respect tothe sheet material, means gas impermeable to the extent needed toprevent excessive gas escape from the treatment zone through the sheetmaterial. Total gas impermeability seldom is needed, particularly forcontinuous flow treatment devices. However, generally highimpermeability is desirable for static treatment devices.

The perimeter of the opening of the liner 100 can have an adhesive stripwith a removable backing. The backing can be removed and the perimeterof the lining can be substantially sealed against the crown 350 (or thecollar 300), thus forming a sealed connection between the perimeter ofthe opening of the liner 100 and the lid 61. Alternatively, the liner100 can be taped to the crown 350 (or the collar 300) to form asubstantial seal between the lid 61 and the liner 100.

In one embodiment, the liner 100 includes a pressure release valve 105built into it. The design of the pressure release valve 105 is notcritical. Many different types are suitable. For example, the valve 105can be a ball valve or a baffle valve such as a flap or butterfly bafflevalve. Other valves are equally suitable, so long as they are capable ofaccurately setting the maximum release pressure and are inexpensive andso discardable. If desired the adjustable valve 105 can be calibrated toshow the pressure setting. In one embodiment, the maximum releasepressure can be set at 22 mm of mercury so that the pressure inside theliner 100 never surpasses that amount of pressure. The valve body can bemade of any rigid plastic, although metals such as stainless steel canbe used also. The spring can be steel or plastic. Very inexpensivecompletely plastic valves can be used as well.

The pressure release valves 105 integrated with the liner 100 areinexpensive yet reliably accurate, within the preferred accuracy ranges.If desired, they can be removed from a used liner 100 and reused on newliners. Using a valve that is in communication with the treatment zoneand not with the gas supply eliminates the need for a separate pressurecontrol mechanism between the chamber 810 and the oxygen source. Thechamber 810 can be connected directly to a gas or oxygen tank or ahospital gas supply line.

With any of the embodiments described herein, a foam cuff 90, as shownin FIG. 3B, is placed around the patient's limb and insertedconcentrically with the cylinder formed by the half circular walls 67and 68. The foam cuff 90 can be disjoined so that it can be opened andplaced around a limb. The foam cuff 90 can be made of a biocompatibleopen cell material that is compressible and resilient and forms asubstantial seal or baffle between the patient's limb and the cylinderformed by the walls 67 and 68. The open cell configuration preventsrapid fluid leakage through the cuff, but does allow for some fluidleakage at pressures approaching 22 mm of mercury, thus acting as abaffle. The pressure inside the treatment zone should not reach 22 mm ofmercury, and the fluid leakage through the foam cuff 90 as the pressureinside the treatment zone increases will prevent pressures from buildingup beyond that level. Thus, with the use of an open cell material in thefoam cuff 90, a pressure release valve 105 in the liner 100 may not benecessary. The foam cuff 90 can also include a backing on its outernon-skin contacting surface that can be peeled away, exposing a stickysurface that sticks to the cylinder. The foam cuff 90 can be made of apolyurethane ester or a natural material.

In one embodiment, the foam cuff 90 is made of a porous material thatgradually vents air or other gas pass through the cuff and out of thetreatment zone. In this manner, the foam cuff acts as a sieve thatpermits air to flow out of the treatment zone such that there is nosudden loss of pressure within the treatment zone. The gas passesgradually over time through the foam cuff out of the treatment zone.

In addition, the foam cuff 90 may comprise a material that acts as afilter for pathogenic material, such as ester open cell foam (e.g.,United States Plastics Corp. Stock No. 47154). Carbon treated or silverimpregnated foam is also suitable. Other types of foam can also be used.The foam cuff is made of a material of sufficient porosity to permit gasto pass through. However, the material collects and captures within thematerial such that the pathogens are prevented from passing through thefilter. The cuff 90 may be made of various materials that provide theproperties described above

FIGS. 5-7B show the vessel 800 in which the patient's wound is treated.The vessel 800 sits inside of the rigid plastic carriage 15 shown inFIG. 1. As shown in FIGS. 5 and 6A, the vessel 800 is formed byinserting chamber 810 into tank 830. The outer dimensions of the chamber810 are slightly smaller than the inner dimensions of the tank 830 sothat the chamber 810 is nested securely within the tank 830. The onlydimension of the tank 830 that is substantially different from thechamber 810 is that the tank 830 is several inches deeper than thechamber 810. This provides for extra room at the bottom of the tank 830for the audio transducer or speaker 870 connected to the bottom of thechamber 810, so that when the chamber 810 is placed in the tank 830, thetop edges 812 and 832 of the chamber 810 and tank 830 are substantiallycoplanar as shown in FIG. 6A.

The tank 830 is made of a molded plastic or metal that is rigid anddurable. As shown in FIGS. 6A and 6B, the tank 830 has a foam platform835 forming an inner bottom surface of the tank 830. The foam platform835 has a circular pipe hole 836 cut into it that receives the audiotransducer or speaker 870. The foam platform 835 has a second pipe hole837 cut into it that is matched up with a hole 838 cut in the bottom ofthe tank 830 to form an outlet port for the water pipe 818 projectingvertically downward from the bottom surface of the chamber 810. Bolts833 projecting vertically downward from the bottom of the tank 830 areused to guide and connect the tank 830 to the carriage 15.

Turning to FIGS. 7A and 7B, chamber 810 is shown in more detail. Thechamber 810 includes a sealing member 813 that surrounds the chamberjust beneath its edge 812. The sealing member 813 forms a substantiallyfluid-tight seal between the chamber 810 and the tank 830. Inside thechamber 810 is an IR board 880 with an array of IR LEDs. The board 880has bolts 881 on its corners that are used to bolt the board 880 to thebottom of the chamber 810. PCB wiring 881 is coupled to the IR board 880and exits from the chamber 810 through hole 882 drilled into the bottomof the chamber 810. The hole 882 can be drilled at a location beneaththe IR board 880 and can be about ¼ inch. Silicone, hot glue, and/orother sealing materials can be used to form a fluid tight seal betweenthe wiring 881 and the hole 882 to seal the chamber 810, hardware, andwires from leaks. The wiring 881 is lead through the pipe hole 837 inthe tank 830 and connects with a connection to the control box.

The IR board 880 includes IR LEDs arranged in a pattern on a square orrectangular board. In one embodiment, the LEDs can emit energy atinfrared frequencies of between about 700 nm and 50,000 nm. The IR board880 can be controlled by the control panel to adjust the frequency. Inone embodiment, the IR LEDs deliver about 2000 mW of infrared light atabout 810 nm. In one embodiment, the IR board 880 can also generateabout 1.2 W of Red light at about 660 nm for a combined total lightoutput of 1911 mW. For example, the IR board 880 can be a Thor DDII IRLamp System.

Turning to FIG. 7A, a hole is drilled through the bottom of the chamber810, and the water pipe 818 is inserted through the hole, projectingvertically downward through the hole and out the bottom of the chamber810. A tub seal pipe coupling 819 is used to form a fluid tight sealbetween the pipe 818 and the hole through which it is inserted throughthe chamber 810. The water pipe 818 is open at both ends to allow waterto flow in and out of the chamber 810 when the chamber 810 is connectedto the reservoir 600 through a water hose.

As shown in FIGS. 7A and 7B, coupled to the outside of the chamber atthe bottom of the chamber 810 is an audio transducer or speaker 870. Thespeaker 870 is bolted to the bottom of the chamber 810. Transducer wires876 are connected to the speaker 870 and, like the IR wiring, arethreaded through the pipe hole 837 in the tank 830 to form a connectionwith the control box. As shown in FIGS. 5 and 6A, a rigid plastic ormetal collar 890 with a hole 892 is placed around the speaker 870 toprotect the speaker 870. The speaker 870 emits energy at a low frequencysound wave of between about 1 Hz and about 1000 Hz. In one embodiment,the speaker emits energy at about 60 Hz. This causes a therapeuticvibration on the chamber 830 and a massaging effect on the patient'slimb.

In one embodiment the foam platform 835 is a premolded piece that isinserted into the bottom of the tank 810, and the chamber 810 is placedon top of the foam 835. In another embodiment, a hardening foam gel ispoured into the bottom of the tank 810 to a predetermined depth, and thechamber 810 with speaker 870 and collar 890 are quickly placed into thetank 810. The foam gel hardens around the pipe 838 and wires 881 and876, the collar 890, and the bottom of the chamber 810. The tank 830 isultimately bolted to the rigid plastic carriage 15.

Now turning to FIGS. 8A and 8B, the components of the wound treatmentsystem 10 that are housed in the cart 40 are shown. Both FIGS. 8A and 8Bare front views of the cart 40 looking at the cart 40 from the directionof viewing the control panel 30. FIG. 8A shows the components with thehumidifier 400 removed so that the water pump 500 is visible. FIG. 8Bshows the components with the humidifier 400 in its normal positionblocking a view of the pump 500, which sits behind the humidifier 400.

As shown in FIG. 8A, a warm water reservoir 600 rests on a shelf 43 atthe bottom of the cart 40. A first hose 510 is connected to the waterpump 500 through fitting 512. The other end of the hose 510 is securedto a hose fitting 630 (shown in FIG. 9B) laterally projecting from thereservoir 600 so that the hose is in fluid communication with the insideof the reservoir 600. A second hose 520 is connected to the water pump500 through fitting 522. The other end of hose 520 is connected to thewater pipe 818 projecting vertically from the bottom of the vessel 800so that the hose 520 is in fluid communication with the inside of thechamber 810. Cables 510 electrically couple the water pump to thecontrol box. The reservoir 600 has a rigid lid 610 that can be removedto expose the inside of the reservoir and fill it with water.

Turning to FIGS. 9A and 9B, the reservoir 600 is shown in more detail.The reservoir 600 includes two float twitches 640 and 650. An upperfloat switch 640 is used to determine when the reservoir 600 is full anda lower float switch 650 is used to determine when the reservoir 600 isempty. Switch 640 has a lead 642 that is electrically connected toterminal block 660 with wire 645. Switch 650 has a lead 652 that iselectrically connected to terminal block 660 with wire 655. Terminalblock 660 is electrically connected to the pump with wires 670. Thespacing between the switches 640 and 650 determines the amount of waterthat will be pumped into the chamber 830 when the system 10 is activatedand the pump function is operating. The switches 640 and 650 arearranged so that the optimal amount of water is pumped into the chamber830. If too much water is pumped into the chamber, the lid 61 candislodge causing the chamber 830 to leak. If there isn't enough water,the patient's limb will not be warmed enough. In one embodiment, aboutfive gallons of water is pumped from the reservoir 600 to the chamber830. When the pump function is activated, the pump begins to pump water500 out of the reservoir 600 through fitting 660. When the water levelreaches the lower switch 650 and the floating arm 653 of the switch 650begins to dip fall, an electrical signal is transmitted to the pump 500through wires 670, and the pump 500 automatically shuts off. When thedrain function is activated, the pump 500 begins to pump in reverse,draining the water from the chamber 830 and back into the reservoir 600.When the water in the reservoir reaches the upper switch 650 and thefloating arm 643 of the switch 640 begins to rise, an electrical signalis transmitted to the pump 500 through wires 670, and the pumpautomatically turns off.

In one embodiment, the water is kept at an optimal temperature with aportable heating unit 680 that is adjustable between a range of about70° F. and about 90° F. In another embodiment, a more sophisticatedheating unit is used (not shown) that is electrically coupled to thecontrol box and can be controlled with a thermostat in the control panel30.

Turning back to FIG. 8B, the humidifier unit 400 sits atop the lid 610of the reservoir 600. The humidifier has a removable lid 410 that can beremoved to fill the reservoir of the humidifier 400 with water and anantibacterial agent, such as ionic silver, hydrogen peroxide,bacitracin, betadine, or isopropyl alcohol. In one embodiment,adiabatically humidified 1% hydrogen peroxide/silver solution is used,but other FDA approved topical antibacterial, antibiotic, antisepticsand antimicrobial solutions and agents, such as those described above,may also be used.

The humidifier 400 has a misting unit that constantly produces mist aslong as the humidifier function on the control panel 30 is activated.The misting unit can be an adiabatic temperature controlled humidifieror ultrasonic nebulizer. The humidifier 400 can generate roomtemperature mist or heated mist. It can include a built-in heater (notshown) with an on/off switch and an indicator light that shows that theheater is on and at operating temperature. Warm mist temperature in thebag 100 can reach between about 77° F. and about 82° F. as measured witha temperature gauge in the lid assembly. The humidity in the bag 100 canreach about 89% to about 98% as measured by a humidity gauge. Thehumidifier has a transducer that generates ultrasonic energy at about 40kHz to create an adiabatic/humid mist that creates a cloud. Ultrasonicenergy from the misting unit is not transmitted to the limb, which isabout two feet away from the misting unit. When the valve control unit50 is opened, the mist travels from the humidifier 400 into the exittube 410 and out through the exit port 420 where it enters the valvecontrol unit 50. From there the mist travels through the tube 70 andinto the treatment zone formed by the bag 100 surrounding the patient'slimb.

Other embodiments are within the scope of the following claims.

1. A wound treatment apparatus comprising: a treatment vessel having atreatment chamber and one or more openings to the treatment chamber thatare each sized to receive a human limb; a removable and substantiallygas impermeable liner that lines the chamber of the vessel and forms atreatment zone around a patient's limb; a mixture tank that holds ahumidifying agent, wherein the mixture tank is in fluid communicationwith the chamber of the vessel; a first array of light emitting diodesthat emits ultraviolet light, wherein the first array of light emittingdiodes is coupled to the vessel near the opening of the treatmentchamber; a speaker attached to the vessel, wherein the speaker deliverslow frequency sound waves to the chamber; and a second array of lightemitting diodes coupled to the chamber, wherein the second array oflight emitting diodes emits pulsed light into the chamber.
 2. Theapparatus of claim 1, wherein the lining comprises a sterile plasticmaterial.
 3. The apparatus of claim 1, further comprising an access portin the chamber for receiving warm water, and wherein the entry of warmwater into the chamber collapses the liner around the patient's limb. 4.The apparatus of claim 1, wherein the first array of light emittingdiodes forms a ring that is concentric with the opening of the chamber.5. The apparatus of claim 1, wherein the first array of light emittingdiodes emits light within a frequency range sufficient to reduce ordestroy bacteria.
 6. The apparatus of claim 5, wherein the first arrayof light emitting diodes emits light within a frequency range of about290 nm to about 260 nm.
 7. The apparatus of claim 1, wherein a hoseconnects the mixture tank with the chamber.
 8. The apparatus of claim 1,further comprising a pump that pumps water out of the chamber.
 9. Theapparatus of claim 1, wherein a humidifier humidifies the mixturecontained in the mixture tank and a hose carries the humidified mixtureto the treatment zone through an inlet port in the vessel.
 10. Theapparatus of claim 1, further comprising an inlet port that is in fluidcommunication with the vessel, wherein oxygen is delivered to thetreatment zone through the inlet port.
 11. The apparatus of claim 1,wherein the second array of light emitting diodes emits infrared light.12. The apparatus of claim 1, wherein the liner comprises a pressurerelease valve that releases gas from the treatment zone at apredetermined pressure setting.
 13. The apparatus of claim 1, whereinthe vessel comprises a lid over the opening of the chamber.
 14. Theapparatus of claim 1 further comprising a cuff that is removably coupledto the opening of the vessel and that is sized to sealingly engage ahuman limb when the limb is inserted through the opening;
 15. Theapparatus of claim 14, wherein the cuff comprises an open cell materialthat naturally leaks fluid, thereby forming a baffle for the treatmentzone.
 16. The apparatus of claim 15, wherein the cuff gradually leaksfluid to prevent a sudden loss of pressure in the treatment zone. 17.The apparatus of claim 14, wherein the cuff comprises a material thatacts as a filter for pathogenic material.
 18. The apparatus of claim 1,wherein a temperature sensor is in fluid communication with thetreatment zone.
 19. The apparatus of claim 1, wherein a humidity sensoris in fluid communication with the treatment zone.
 20. The apparatus ofclaim 1, wherein a pressure sensor is in fluid communication with thetreatment zone.
 21. A wound treatment system comprising: a vessel thatis sized to receive a human limb, the vessel comprising a chamber withat least one opening leading into the chamber; a removable andsubstantially gas impermeable liner that lines the chamber of the vesseland forms a treatment zone; a humidifier that humidifies a solution ofwater and antibacterial agent, wherein the humidifier is in fluidcommunication with the treatment zone; an oxygen source that is in fluidcommunication with the treatment zone; a speaker coupled to the vessel,wherein the speaker emits low frequency sound waves to the chamber; afirst array of light emitting diodes that emits ultraviolet light,wherein the first array of light emitting diodes is coupled to thevessel near the opening of the treatment chamber and wherein the firstarray of light emitting diodes emits light within a frequency rangesufficient to reduce or destroy bacteria; a second array of lightemitting diodes coupled to the chamber, wherein the second array oflight emitting diodes emits pulsed light into the chamber; and a controlpanel.
 22. The wound treatment system of claim 21, wherein thehumidifier comprises an adiabatic humidifier.
 23. The wound treatmentsystem of claim 22, wherein the adiabatic humidifier uses ultrasonicenergy to form a mist from the solution of water and antibacterialagent.
 24. The wound treatment system of claim 21, wherein the controlpanel comprises: a humidifier control that controls the operation of thehumidifier; an ultraviolet light control that controls the first arrayof light emitting diodes; an infrared light control that controls thesecond array of light emitting diodes; a audio control that controls thespeaker; and a master power switch.
 25. The wound treatment system ofclaim 21, wherein the second array of light emitting diodes emitsinfrared light.
 26. The wound treatment system of claim 21, furthercomprising a source of warm fluid that is in fluid communication withthe chamber.
 27. The wound treatment system of claim 21, furthercomprising a pump that pumps the warm fluid out of the chamber.
 28. Thewound treatment system of claim 21, wherein the control panel comprisesa manual control switch that permits manual operation of the system. 29.The wound treatment system of claim 21, wherein the control panelcomprises an auto control switch that permits automatic operation of thesystem according to a predetermined regimen.
 30. The wound treatmentsystem of claim 21, wherein the auto control switch comprises aplurality of auto settings corresponding to a plurality of predeterminedregimens.
 31. The wound treatment system of claim 21, further comprisinga foam cuff that is coupled to a limb of a patient, wherein the cuff issized to substantially form a seal between the limb and the opening ofthe chamber.
 32. The wound treatment system of claim 31, wherein thefoam cuff comprises an open cell material that slowly leaks fluid. 33.The wound treatment system of claim 31, wherein the foam cuff comprisesa material that acts as a filter for pathogenic material.
 34. The woundtreatment system of claim 21, further comprising an oximeter that iscoupled to the patient's skin, wherein the oximeter is in electricalcommunication with control circuitry integrated with the control panel.35. The wound treatment system of claim 21, further comprising apressure sensor in communication with the treatment zone.
 36. The woundtreatment system of claim 21, further comprising a humidity sensor incommunication with the treatment zone.
 37. The wound treatment system ofclaim 21, further comprising a temperature sensor in communication withthe treatment zone.
 38. The wound treatment system of claim 21, furthercomprising a housing that contains at least a portion of the woundtreatment system, and wherein the oxygen source comprises an oxygen tankor an O2 concentrator contained in the housing.
 39. The wound treatmentsystem of claim 21, further comprising a wireless transmitter adapted totransmit data.
 40. The wound treatment system of claim 21, furthercomprising a barcode data reader for reading data.
 41. A wound treatmentmethod for treating a wounded limb comprising: cleaning the wound;disinfecting the limb by passing the limb through a ring of ultravioletlight emitting diodes that emit ultraviolet light on the limb as thelimb passes through the ring; placing a cuff around the limb; placingthe limb into a vessel comprising a chamber that is lined with asubstantially gas impermeable liner, wherein the cuff substantiallyforms a seal with an opening of the chamber thereby forming asubstantially gas impermeable treatment zone around a portion of thelimb distal the cuff; heating the limb by introducing warm water intothe chamber thereby collapsing the liner around the patient's limb;emptying the water out of the chamber; introducing a temperaturecontrolled mist of water and an antibacterial solution into thetreatment zone; massaging the limb by activating a speaker coupled tothe vessel that transmits low frequency sound waves to the treatmentzone; heating the limb by activating an array of light emitting diodescoupled to the vessel that emits pulsed light onto the limb; andintroducing oxygen into the treatment zone.
 42. The method of claim 41,wherein the pulsed light comprises infrared light.
 43. The method ofclaim 41, wherein the antibacterial agent comprises ionic silver,hydrogen peroxide, bacitracin, betadine, or isopropyl alcohol.
 44. Themethod of claim 41, wherein the antibacterial agent comprises anadiabatically humidified hydrogen peroxide/silver solution.
 45. Themethod of claim 41, further comprising monitoring the patient's bloodoxygen level using an oximeter.
 46. The method of claim 45, furthercomprising discontinuing treatment if the patient's blood oxygen levelreaches a predetermined level.
 47. The method of claim 41, wherein thespeaker transmits at a frequency about 440 Hz.
 48. The method of claim41, wherein the oxygen displaces the mist.